LifeVest Post-CABG Registry
This study is currently recruiting participants.
Verified April 2013 by Zoll Medical Corporation
Sponsor:
Zoll Medical Corporation
Information provided by (Responsible Party):
Zoll Medical Corporation
ClinicalTrials.gov Identifier:
NCT01448005
First received: October 4, 2011
Last updated: April 24, 2013
Last verified: April 2013
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Purpose
This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing arrhythmic death in this select population with high risk for sudden cardiac death (SCD). This is a pilot project to determine the feasibility of a larger-scale study.
| Condition | Intervention |
|---|---|
|
Sudden Cardiac Death Ventricular Fibrillation Ventricular Tachycardia Ventricular Dysfunction Myocardial Ischemia |
Device: wearable defibrillator (LifeVest) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery |
Resource links provided by NLM:
Further study details as provided by Zoll Medical Corporation:
Primary Outcome Measures:
- number of patients who experience sudden cardiac death [ Time Frame: three months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- number of patients who experience inappropriate shocks [ Time Frame: three months ] [ Designated as safety issue: Yes ]
- hours per day of wearable defibrillator use [ Time Frame: three months ] [ Designated as safety issue: No ]
- number of patients who experience sudden cardiac arrest [ Time Frame: three months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
wearable defibrillator use
subjects will use a wearable defibrillator
|
Device: wearable defibrillator (LifeVest)
A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who have undergone CABG surgery during current hospitalization and have an ejection fraction ≤ 35% following the surgery.
Criteria
Inclusion Criteria:
- Patients who have undergone CABG surgery during current hospitalization
- Patients who have an ejection fraction ≤ 35% following the surgery.
- Patients who have dilated cardiomyopathy or prior myocardial infarction.
- Patients who are prescribed a wearable defibrillator following surgery.
- Patient who are at least 18 years old.
Exclusion Criteria:
- Patients who have an active ICD.
- Patients who have an active unipolar pacemaker.
- Patients having a chest circumference over 56 inches or under 26 inches.
- Patients who are unable to consent or unwilling to wear the WCD after discharge or who do not agree to be contacted at 90 days.
- Patients with a mental, visual, physical or auditory deficit that could impair their ability to properly interact with a wearable defibrillator.
- Patients participating in another clinical study with mortality as the primary endpoint.
- Patients unable to use a wearable defibrillator due to physical conditions (bandages preventing electrode contact, physical deformities preventing electrode contact, dextrocardia, etc.).
- Patients who have decided to forgo resuscitation.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448005
Contacts
| Contact: Steven J Szymkiewicz, MD | 412-968-3333 ext 4400 | sszymkiewicz@zoll.com |
Locations
| United States, California | |
| Sutter Heart and Vascular Institute | Recruiting |
| Sacramento, California, United States, 95819 | |
| Contact: John Chin, MD 916-736-2323 jchin@rcamd.com | |
| Contact: Beverly Seiler, RN 916-733-8169 seilerb@sutterhealth.org | |
| Principal Investigator: John Chin, MD | |
| United States, Georgia | |
| Saint Joseph's Health System, Inc. | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Jeffrey S Miller, MD 404-256-6104 jeffrey.miller@emoryhealthcare.org | |
| Contact: Michele Fielding, RN 678-843-6094 michele.fielding@emoryhealthcare.org | |
| Principal Investigator: Jeffrey S Miller, MD | |
| United States, Maryland | |
| Washington Adventist Hospital | Recruiting |
| Takoma Park, Maryland, United States, 20912 | |
| Contact: Sean C Beinart, MD 301-670-3000 sbeinart@gmail.com | |
| Contact: Melissa L Ramey, RN 301-891-5024 mramey2@adventisthealthcare.com | |
| Principal Investigator: Sean Beinart, MD | |
| Sub-Investigator: Anthony Rongione, MD | |
| Sub-Investigator: Paul Massimiano, MD | |
| United States, Texas | |
| Texas Heart Institute, St. Luke's Episcopal Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: C. David Collard, MD 832-355-2666 ccollard@sleh.com | |
| Contact: Carliss Ramos, RN 832-355-8388 cramos@texasheart.org | |
| Principal Investigator: C. David Collard, MD | |
| Sub-Investigator: Wei Pan, MD | |
| United States, Virginia | |
| Chippenham Johnston-Willis Medical Center | Recruiting |
| Richmond, Virginia, United States, 23225 | |
| Contact: Thomas D Christopher, MD 804-320-2751 thomas.christopher@hcahealthcare.com | |
| Contact: Margaret T Wittenbraker, ACNP 804-320-2751 margaret.wittenbraker@hcahealthcare.com | |
| Principal Investigator: Thomas D Christopher, MD | |
| Sub-Investigator: Graham M Bundy, MD | |
| Sub-Investigator: Leo M Gazoni, MD | |
| Sub-Investigator: Dipin Gupta, MD, MBA | |
| Sub-Investigator: Chiwon Hahn, MD | |
| Sub-Investigator: Joseph J Zocco, MD | |
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
| Study Director: | Steven J Szymkiewicz, MD | Zoll Medical Corporation |
More Information
No publications provided
| Responsible Party: | Zoll Medical Corporation |
| ClinicalTrials.gov Identifier: | NCT01448005 History of Changes |
| Other Study ID Numbers: | 90D0107 |
| Study First Received: | October 4, 2011 |
| Last Updated: | April 24, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Zoll Medical Corporation:
|
Coronary Artery Bypass Grafting Resuscitation Sudden Cardiac Death Ventricular Dysfunction |
Additional relevant MeSH terms:
|
Myocardial Ischemia Coronary Artery Disease Death Ischemia Tachycardia Ventricular Fibrillation Tachycardia, Ventricular Death, Sudden, Cardiac Ventricular Dysfunction Heart Diseases |
Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes Arrhythmias, Cardiac Heart Arrest Death, Sudden |
ClinicalTrials.gov processed this record on May 23, 2013